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Yahoo
11-03-2025
- Business
- Yahoo
Novavax Announces Changes to Board of Directors
James Young, PhD retires as Chair of the Board, Margaret McGlynn, RPh, appointed John Shiver, PhD appointed to board of directors GAITHERSBURG, Md., March 11, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced that James Young, PhD, is retiring as Chair of the Board and Margaret McGlynn, RPh, has been appointed as his successor. The Company also appointed John Shiver, PhD, to its board as an independent director. Dr. Young made the decision to resign from the board effective March 10, 2025. He has served on Novavax's board since 2010 and as Chair since 2011. During his tenure, the Company acquired Isconova and the Matrix-M™ adjuvant, now a key component of its technology platform. Novavax also earned global approvals for and commercialized its first vaccine ever for COVID-19, ramping up quickly to meet the demands of the global pandemic. Dr. Young helped to guide the Company through the partnership with Sanofi in 2024 and the subsequent transformative focus on a new corporate growth strategy to maximize the impact of Novavax's cutting-edge technology by focusing on strategic partnerships for its research and development (R&D) assets and its Matrix-M™ adjuvant. "We'll forever be grateful for Jim's leadership during such critical moments for Novavax over the past 15 years," said John C. Jacobs, President and Chief Executive Officer, Novavax. "With the solid foundation he helped build, we look forward to advancing our corporate growth strategy with Margie at the helm of the board, and now with John's guidance as well. Both Margie and John bring a wealth of experience and under the collective leadership of all of our board members, we are well-positioned to deliver for our shareholders." Ms. McGlynn has served on Novavax's board of directors since 2020. She previously served as President, Merck Vaccines and Infectious Disease, and after 26 years at Merck, served as CEO of the International AIDS Vaccine Initiative. She also serves on the board of directors of Amicus Therapeutics and University at Buffalo Foundation. "Thanks to Jim's leadership, Novavax is primed to deliver against an exciting new pipeline through strategic collaborations," said Ms. McGlynn. "I look forward to working with this immensely talented board and executive leadership team to support Novavax as it moves into a position of strength over the coming years." Dr. Shiver has more than 30 years of vaccine, biologics and RNA therapeutics experience in pharmaceutical research and development. He has led teams of scientists to develop novel vaccine and monoclonal antibody candidates to prevent or treat more than 40 infectious and non-infectious diseases. Dr. Shiver has also created a machine learning/artificial intelligence group to help design new vaccine candidates. He has served on multiple scientific advisory boards and committees including the International AIDS Vaccine Initiative Board of Directors and the Board of Directors for Icosavax, Auravax and Calder Biosciences. Dr. Shiver is a Special Advisor to F Prime Capital and serves as Head of R&D and an Observer of the board of directors at Vibrant Biomedicines. His past experience includes roles at IGM ID, Sanofi Pasteur, Merck and the National Cancer Institute. Dr. Shiver holds a Bachelor of Science degree in Chemistry and Mathematics from Wofford College and a Doctor of Philosophy in Physical Chemistry from the University of Florida. About NovavaxNovavax, Inc. (Nasdaq: NVAX) tackles some of the world's most significant health challenges by leveraging its scientific expertise in vaccines and its cutting-edge technology platform, including a protein-based nanoparticle and Matrix-M™ adjuvant. The Company's growth strategy is focused on building new and diversified partnerships via the out-licensing of its technology platform and vaccine assets earlier in the development process. These strategic collaborations are fueled by smart investments in a growing early-stage pipeline starting with the Company's core expertise in infectious disease and potentially expanding into other disease areas. Please visit and LinkedIn for more information. Forward-Looking StatementsStatements herein other than statements of historical fact, including statements relating to the Company's corporate growth strategy, the composition of its Board of Directors, and expectations regarding its clinical pipeline through strategic collaborations, are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges or delays in obtaining regulatory authorization or approval for its COVID-19 vaccine, in particular with respect to its Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for approval of its COVID-19 vaccine, or its other product candidates, including for future COVID-19 variant strain changes, its COVID-19-Influenza-Combination (CIC) vaccine candidate, its stand-alone influenza vaccine candidate or other product candidates; Novavax's ability to successfully and timely manufacture, market, distribute, or deliver its updated 2024-2025 formula COVID-19 vaccine and the impact of its not having received a BLA from the FDA for the 2024-2025 vaccination season; challenges related to Novavax's partnership with Sanofi and in pursuing additional partnership opportunities; challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification, assay validation and stability testing, necessary to satisfy applicable regulatory authorities; challenges or delays in conducting clinical trials or studies for its product candidates; manufacturing, distribution or export delays or challenges; Novavax's substantial dependence on Serum Institute of India and Serum Life Sciences Limited for co-formulation and filling Novavax's COVID-19 vaccine and the impact of any delays or disruptions in their operations; difficulty obtaining scarce raw materials and supplies including for its proprietary adjuvant; resource constraints, including human capital and manufacturing capacity; constraints on Novavax's ability to pursue planned regulatory pathways, alone or with partners; challenges in implementing its global restructuring and cost reduction plan; Novavax's ability to timely deliver doses; challenges in obtaining commercial adoption and market acceptance of its updated 2024-2025 formula COVID-19 vaccine or any COVID-19 variant strain containing formulation, or for its CIC vaccine candidate and stand-alone influenza vaccine candidate or other product candidates; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities, including requirements to deliver doses that may require Novavax to refund portions of upfront and other payments previously received or result in reduced future payments pursuant to such agreements and challenges in amending or terminating such agreements; challenges related to the seasonality of vaccinations against COVID-19 or influenza; challenges related to the demand for vaccinations against COVID-19 or influenza; challenges in identifying and successfully pursuing innovation expansion opportunities, including with respect to Novavax's Matrix-M adjuvant; Novavax's expectations as to expenses and cash needs may prove not to be correct for reasons such as changes in plans or actual events being different than its assumptions;; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at and for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Contacts: InvestorsLuis Sanay, CFA240-268-2022ir@ MediaGiovanna Chandler202-709-5563media@ View original content to download multimedia: SOURCE Novavax, Inc. Sign in to access your portfolio
CBC
04-02-2025
- Health
- CBC
Ebola vaccine trial begins in Uganda amid outbreak
Social Sharing Ugandan authorities launched on Monday a clinical trial of a vaccine against the Sudan strain of Ebola that has killed one nurse in the capital, Kampala. The 32-year-old male nurse died on Wednesday, and was confirmed to have had the Sudan strain through postmortem tests, Diana Atwine, permanent secretary of the health ministry, told reporters. The vaccine clinical trial is enrolling health workers and others who have been exposed to the virus. On Jan. 30, Uganda declared an outbreak of Ebola. The total number of cases have now risen to three, with the two additional cases from the family of the deceased, Ministry of Health spokesperson Emmanuel Ainebyoona told Reuters late on Monday. Officials are investigating the source of the outbreak. The World Health Organization is collaborating with Uganda's Ministry of Health, the Uganda Virus Research Institute, and the Makerere University Lung Institute to conduct the trial of the vaccine, which was developed by Merck and provided by the International AIDS Vaccine Initiative. Here are some factors that set this Ebola outbreak apart from previous ones. The virus Ebola infection symptoms include hemorrhage, headache and muscle pains. This outbreak is of the Sudan virus disease, part of the Ebola viral family, and involves similar symptoms. It's a severe, often fatal illness affecting humans and other primates, according to the WHO. It's typically transmitted through contact with the bodily fluids of an infected person or contaminated materials. Uganda has experienced five previous Ebola outbreaks, including one in 2000 that killed hundreds, the WHO said. The other main type of Ebola is called Zaire. "Sudan can be as aggressive as Zaire," with similar signs and symptoms, said Gary Kobinger, who worked at Canada's National Microbiology Laboratory and helped design a vaccine for the Zaire type of Ebola. What's concerning, he said, is there isn't yet an approved vaccine for Sudan, and therapeutics for it aren't as advanced. Uganda's new outbreak Health workers and others potentially exposed to the virus are being offered more doses of the candidate vaccine, according to the International AIDS Vaccine Initiative (IAVI), which provided the vaccine. Kampala has a highly mobile population of about four million, which could make contact tracing — a key to stemming spread — more challenging. The nurse who died had sought treatment at a hospital just outside the capital and later travelled to Mbale in the country's east, where he was admitted to a public hospital. Health authorities said he also sought the services of a traditional healer. Dr. Craig Spencer, an associate professor of public health and emergency medicine at Brown University in Rhode Island, treated Ebola patients in Guinea and recovered from it himself in New York in 2014. "Without knowing where the initial case is coming from and the potential for there to be further spread, especially within health-care facilities in the capital, it is definitely a time of heightened concern," said Spencer. At least 234 contacts have been identified in this outbreak, according to Uganda's Ministry of Health. Speed of response The vaccine candidate was prepared and ready to be deployed in Uganda, Spencer said. As a result, within days of the outbreak being declared, the clinical trial kicked off, said WHO director general Tedros Adhanom Ghebreyesus in a social media post. The trial will evaluate whether the candidate is efficacious. Uganda learned from its outbreak of the Sudan type of Ebola two years ago, Spencer said. At the time, a vaccine trial wasn't ready to be conducted before the outbreak ended. IAVI said its Ebola Sudan vaccine candidate uses the same viral vector platform as Merck's single-dose Zaire Ebola virus vaccine. WATCH | Uganda's 2022 Ebola outbreak: Ebola spreads in Uganda as country waits for experimental vaccine 2 years ago Duration 2:04 "Overall, it's a very similar vaccine, adapted for Sudan," Kobinger said. But given there's a few changes, it needs to be tested in human clinical trials, he said. This is the first Ebola outbreak since the Trump administration's decision last week to withdraw from the UN health agency. The United States is by far the WHO's biggest financial backer, contributing around 18 per cent of its overall funding. WHO's most recent two-year budget, for 2024-25, was $6.8 billion US. It's also the first such outbreak since Trump's order for a freeze on foreign assistance. Dr. Isaac Bogoch, an infectious diseases specialist at Toronto General Hospital, said a well-funded and functional WHO is especially important in an era of emerging and re-emerging infectious diseases. "This could become a much larger regional problem and unfortunately, even global problem if these aren't dealt with appropriately and quickly," Bogoch said. "It's also the right thing to do and the humane thing."
Yahoo
04-02-2025
- Health
- Yahoo
WHO prioritises IAVI Sudan Ebola vaccine ring trial amid Uganda outbreak
A Sudan Ebola vaccine, provided by the International AIDS Vaccine Initiative (IAVI), is being investigated in a Uganda vaccine trial that was launched just four days after the country declared an outbreak. The vaccine is being investigated as part of a ring trial led by the World Health Organization (WHO) at Makerere University Lung Institute in the Ugandan capital, Kampala. Evaluation of the recombinant vesicular stomatitis virus (rVSV) vaccine has been prioritised as part of a global collaborative effort supporting the country's Ebolavirus outbreak. Principal investigators from Makerere University and the Uganda Virus Research Institute (UVRI), with support from WHO and other partners, including Uganda's Ministry of Health, prepared the randomised trial to begin the first dosing just four days after the outbreak was confirmed on 30 January. Dosing began at the Mulago Referral Hospital in the capital yesterday (3 February) after three vaccination rings were defined. The first ring involves approximately 40 contacts from the first reported and confirmed case, a health worker who died on 29 January. The efficacy of ring trials was established in a study published in the New England Journal of Medicine, which evaluated trials of MSD's rVSV vaccine Ervebo that was investigated in the Zaire Ebola outbreak in the Democratic Republic of Congo. IAVI president Dr Mark Feinberg said: 'We believe this clinical trial represents an important step toward evaluating the potential of IAVI's vaccine to protect exposed individuals from Ebola Sudan infection, as well as demonstrating its value as a safe, effective, and accessible new tool to include in comprehensive outbreak responses in the future. "Critically, having vaccine doses readily available in the country made it possible for us all to mobilise in just days and to be able to incorporate the evaluation of a promising Ebola Sudan vaccine clinical trial into the public health response very soon after the first reports of the current outbreak.' This will be the first trial to assess the clinical efficacy of a vaccine against Ebola disease due to the Sudan virus. In 2023, IAVI initiated a Phase I trial (NCT05724472) which determined the rVSV Ebola Sudan vaccine was well tolerated with immune responses detected in all groups. This data was shared in November 2024 during the annual meeting American Society of Tropical Medicine and Hygiene. IAVI is also investigating the rVSV platform technology elsewhere in its portfolio, including a Lassa virus vaccine candidate currently in Phase II trials in West Africa. Evaluation of IAVI's Ebola Sudan vaccine was already prepositioned in the country, however, the recent outbreak has seen the WHO sign an agreement for IAVI to provide more doses of the shot. The most recent Ebola outbreak is the sixth the country has faced, the last being in 2022. The virus causes severe haemorrhagic fever disease and holds a fatality rate of between 41% and 70%. Although several promising candidate medical countermeasures are progressing through clinical development, there are no vaccines or therapeutics approved for Ebola Sudan. Ebola Zaire vaccines are not effective in protecting against Ebola Sudan. During the 2022 outbreak, a randomised protocol for candidate vaccines was developed with teams trained in good clinical practice (GCP) and standard operating procedures of how to run studies during a national outbreak. Staff completed refresher training in recent days. WHO colleagues experienced in trials and ring vaccination arrived in Uganda over the weekend to support the trial implementation and GCP compliance. According to GlobalData's Pharmaceutical Intelligence Centre, there are 16 Ebola drugs in active clinical development, ten in Phase I, two in Phase II, and four in Phase III. Just one of the Phase III candidates, a combination of Johnson and Johnson's Mvabea and Zabdeno, is being investigated in Ebola Sudan. The Mvebea and Zabdeno regiment is approved for the Zaire ebolavirus. GlobalData is the parent company of Clinical Trials Arena. "WHO prioritises IAVI Sudan Ebola vaccine ring trial amid Uganda outbreak" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
